Phase 3
Completed N=312
Efficacy and Safety of Alogliptin Used in Combination With Sulfonylurea in Participants With Type 2 Diabetes in Japan
Source: ClinicalTrials.gov NCT01318083 ↗Enrolled (actual)
312
Serious AEs
1.3%
Results posted
Jul 2011
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (Week 12). — -0.60; -0.66; 0.34 percentage of Glycosylated Hemoglobin
Summary
The purpose of this study was evaluate the efficacy and safety of alogliptin, once daily (QD) combined with an Sulfonylurea taken QD or twice daily (BID) in type 2 diabetic patients with uncontrolled blood glucose.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (Week 12). |
-0.60; -0.66; 0.34 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 2). |
-0.12; -0.13; 0.08 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 4). |
-0.32; -0.36; 0.09 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 8). |
-0.52; -0.59; 0.18 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 2). |
-17.5; -17.4; 0.2 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 4). |
-21.2; -22.9; 2.0 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 8). |
-22.3; -17.4; 5.3 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 12). |
-22.3; -15.9; 6.0 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12). |
76.6; 80.9; 100.0 | — |
Eligibility Criteria
Inclusion Criteria
- Had been taking a sulfonylurea for at least 4 weeks prior to the initiation of the observation period (Week -12).
- Had been taking glimepiride at a stable dose regimen (1, 2, 3 or 4 mg/day, once or twice daily in the morning or in the morning and evening, before or after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0).
- Had glycosylated hemoglobin (HbA1c) of 7.0% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).
- Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%* of the value at 4 weeks after the initiation of the observation period (Week -8) (*rounded off to the first decimal place).
- Was receiving specific diet and exercise (if any) therapies during the observation period.
Exclusion Criteria
- Had taken other diabetic medications than glimepiride within 12 weeks before the initiation of the treatment period (Week 0).
Data sourced from ClinicalTrials.gov (NCT01318083). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.